NCT04125589

Brief Summary

The investigators are doing a study of women with and without binge-eating disorder to learn more about what happens when people engage in everyday decision-making activities. The investigators are interested in learning more about brain activity during everyday decision-making and how everyday decision-making relates to a variety of daily experiences. Examples of everyday decisions include deciding which product to buy, deciding what to eat for a snack, and deciding how to spend free time.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 14, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

December 31, 2019

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2025

Completed
Last Updated

January 14, 2026

Status Verified

September 1, 2025

Enrollment Period

5.5 years

First QC Date

September 27, 2019

Last Update Submit

January 13, 2026

Conditions

Binge-Eating Disorder

Keywords

Binge-Eating DisorderDecision-MakingBrain Activity

Outcome Measures

Primary Outcomes (3)

  • Decision-making behavior (actual decisions)

    Decisions (i.e., percent of goal-inconsistent decisions from challenge trials)

    Up to 1 hour post-intervention

  • Decision-related BOLD activation (reward regions-of-interest)

    Percent change in blood oxygen level-dependent (BOLD) signal in response to decision making in regions involved in reward (e.g., nucleus accumbens, insula)

    Up to 1 hour post-intervention

  • Decision-related BOLD activation (executive function regions-of-interest)

    Percent change in blood oxygen level-dependent (BOLD) signal in response to decision making in regions involved in executive function (e.g., dorsolateral prefrontal cortex, inferior frontal gyrus)

    Up to 1 hour post-intervention

Study Arms (2)

Speaking Activity and Talking Activity

EXPERIMENTAL

Participants will engage in a speaking activity first and a talking activity second.

Behavioral: Speaking ActivityBehavioral: Talking Activity

Talking Activity and Speaking Activity

EXPERIMENTAL

Participants will engage in a talking activity first and a speaking activity second.

Behavioral: Speaking ActivityBehavioral: Talking Activity

Interventions

Speaking ActivityBEHAVIORAL

Participants will engage in a speaking activity where they are given a topic to speak about.

Speaking Activity and Talking ActivityTalking Activity and Speaking Activity
Talking ActivityBEHAVIORAL

Participants will engage in a talking activity where they may talk about a topic of their choice.

Speaking Activity and Talking ActivityTalking Activity and Speaking Activity

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSubjects must identify as female.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal or corrected to normal vision and hearing
  • Verbal and written fluency in English
  • Right-handed
  • Body mass index of 20-35 kg/m\^2
  • DSM-5 binge-eating disorder

You may not qualify if:

  • Impaired cognition or other neurological/cognitive problems
  • Contraindications to MRI (e.g., certain metal implants, claustrophobia)
  • Currently/recently/potentially pregnant, seeking to become pregnant in the near future, or breastfeeding
  • Serious and/or unstable medical diseases and conditions, and certain other medical diseases and conditions
  • Recent low weight
  • Certain medications (e.g., insulin)
  • Current/recent frequent recreational drug use, or history of frequent recreational drug use in early adolescence
  • Extreme dietary limitations (e.g., veganism), pervasive food allergies, or limited exposure to popular snack foods
  • Current/recent suicidality
  • Current/recent changes in treatment for mental illness
  • Study-relevant research experience
  • Personal history of eating disorders or recurrent binge eating
  • Personal history of any other mental illness, including serious substance use problems
  • First-degree relative with current or past eating or psychotic disorder
  • Significant recent change in weight
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Binge-Eating Disorder

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Kristin N Javaras, DPhil, PhD

    Mclean Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Psychologist, Division of Women's Mental Health, McLean Hospital; Assistant Professor of Psychology, Department of Psychiatry, Harvard Medical School

Study Record Dates

First Submitted

September 27, 2019

First Posted

October 14, 2019

Study Start

December 31, 2019

Primary Completion

June 27, 2025

Study Completion

June 27, 2025

Last Updated

January 14, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Locations

US(1)